Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT03624205
Status:
UNKNOWN
Last Update Posted:
2018-08-10
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2022-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-08-08', 'studyFirstSubmitDate': '2018-08-07', 'studyFirstSubmitQcDate': '2018-08-08', 'lastUpdatePostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Target Lesion Failure in 12 months after operation', 'timeFrame': '1 year', 'description': 'To measure Target Lesion Failure in 12 months by using angiography'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary In Sentrestenosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of paclitaxel -eluting PTCA- balloon (SeQuent® Please) in real world Chinese Coronary In Sentrestenosis patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patient with coronary In sentrestenosis', 'eligibilityCriteria': "Inclusion Criteria:\n\nCriteria related to subjects\n\n* At the age of 18-80, Both male and female;\n* Patients with coronary In sentrestenosis and suitable for the theory of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）, no more than 1 target lesion in each coronary artery\n* After pre-dilation of target lesion, the residual stenosis is ≥ 30% , patients with type B dissection\n* Patients must agree to sign the ICF and to undergo the clinical follow-up at 30 days, 6 months, 6 months, 12 months, 24 months, 36months, 48 months and 60 months after operation Criteria related to lesions\n* The target lesion length and target vessel diameter should be consistent with the instructions of Drug Eluting PTCA Balloon Catheter（SeQuent® Please）\n\nExclusion Criteria:\n\nCriteria related to subjects\n\n* Women with pregnancy or lactation\n* Patient with cardiac shock\n* Patients with Hemorrhagic physique or active gastrointestinal ulcers, with cerebral apoplexy or transient cerebral ischemia within 3 months, who couldn't be tolerated the expected aspirin and/or clopidogrel theory\n* Patients with severe valvular heart disease\n* Patients with severe congestive heart failure or NYHA class IV heart failure;\n* Patients who have received heart transplant;\n* Patients with life expectancy more than 60 months, or those who is difficulties in clinical follow-up.\n* Patients who are currently involved in any other clinical trial;\n* Patients that the investigators think that those are not suitable Criteria related to lesions\n* Chronic total occlusion\n* Lesion that cannot be treated with PTCA or other interventional techniques;\n* The vessel diameter \\< 2.25 mm\n* Left main disease needed to be treated Exclusion criteria related to concomitant medication\n* Patients who are intolerant to aspirin and/or clopidogrel or have a history of neutrophilopenia or thrombocytopenia, or patients with severe hepatic insufficiency and contraindicated for clopidogrel.\n* Patients who are known to be intolerant or allergic to heparin, contrast agent, paclitaxel, iopromide, rapamycin, polylactic acid - glycolic acid polymer, stainless steel;"}, 'identificationModule': {'nctId': 'NCT03624205', 'briefTitle': 'The Safety and Efficacy of SeQuent® Please in Real World Chinese Coronary Instent Restenosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'B. Braun Medical International Trading Company Ltd.'}, 'officialTitle': 'To Evaluate the Long Term Safety and Efficacy of Drug Coated Balloon SeQuent® Please in Chinese Coronary Instent Restenosis Patients,a Prospective, Multi-center,Randomization Clinical Trial.', 'orgStudyIdInfo': {'id': 'AAG-O-H-1414'}}, 'armsInterventionsModule': {'interventions': [{'name': 'paclitaxel-releasing coronary balloon (SeQuent® Please)', 'type': 'DEVICE', 'description': 'SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'B. Braun Medical International Trading Company Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}